Senior Process Development Engineer

Senior Process Development EngineerLocation: Puerto RicoWork Model: OnsiteLong Term Project

We are seeking a Senior Process Development Engineer to lead manufacturing process development, validation, optimization, and production-readiness activities within a regulated medical device manufacturing environment.
Key Responsibilities:Lead process development, characterization, optimization, and validation activities.Execute/support IQ/OQ/PQ, TMV, DOE, statistical analysis, and process capability studies.Support NPI, manufacturing transfer, process implementation, troubleshooting, and root-cause analysis.Develop and review PFMEA, work instructions, process specifications, validation protocols, and reports.Collaborate with Manufacturing, Quality, R&D, Operations, Supply Chain, and Regulatory teams.Provide technical leadership and coordinate onsite and offshore engineering resources.Support manufacturing data and documentation in SAP and Agile PLM.
Requirements:Bachelor’s degree in Mechanical, Manufacturing, Biomedical, Industrial Engineering, or related field.7+ years of engineering experience, preferably within medical device or regulated manufacturing.Strong hands-on experience with manufacturing process development and validation.Experience with IQ/OQ/PQ, TMV, DOE, statistics, and process capability/Cpk.Knowledge of PFMEA, risk management, change control, and medical-device quality systems.Strong technical leadership and communication skills.SAP, Agile PLM, NPI/manufacturing transfer, and offshore/global engineering experience are highly preferred.Bilingual English/Spanish is a plus.